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Effects of Growth Hormone Releasing Hormone in HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01263717
Recruitment Status : Completed
First Posted : December 21, 2010
Results First Posted : October 13, 2014
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV
HIV Lipodystrophy
Interventions Drug: tesamorelin
Drug: placebo
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Period Title: Overall Study
Started 28 26
Baseline Visit 28 22
Completed 23 20
Not Completed 5 6
Arm/Group Title Tesamorelin Placebo (Inactive Injection) Total
Hide Arm/Group Description Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase Total of all reporting groups
Overall Number of Baseline Participants 28 22 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 28 participants 22 participants 50 participants
49
(46 to 54)
53
(49 to 58)
51.5
(46 to 56.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 22 participants 50 participants
Female
4
  14.3%
4
  18.2%
8
  16.0%
Male
24
  85.7%
18
  81.8%
42
  84.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 28 participants 22 participants 50 participants
White 20 14 34
Black 6 3 9
Hispanic 1 3 4
Other 1 2 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 22 participants 50 participants
28 22 50
1.Primary Outcome
Title Liver Fat
Hide Description Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 22 19
Median (Inter-Quartile Range)
Unit of Measure: Change in hepatic lipid-to-water %
-2.0
(-6.4 to 0.1)
0.9
(-0.6 to 3.7)
2.Primary Outcome
Title Visceral Adipose Tissue
Hide Description Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 24 20
Mean (95% Confidence Interval)
Unit of Measure: change in cm^2 after 6 months
-34
(-53 to -15)
8
(-14 to 30)
3.Secondary Outcome
Title Intramyocellular Lipid
Hide Description Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 23 20
Median (Inter-Quartile Range)
Unit of Measure: Change in ratio of IMCL/Cr
-1.7
(-3.9 to 0.7)
-0.2
(-5.2 to 5.5)
4.Secondary Outcome
Title Endogenous Growth Hormone Secretion
Hide Description Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for some subjects.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 21 15
Median (Inter-Quartile Range)
Unit of Measure: Change in ng/mL
0.35
(0.15 to 0.57)
-0.01
(-0.07 to 0.06)
5.Secondary Outcome
Title Insulin Sensitivity
Hide Description In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for some subjects.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 10 9
Mean (95% Confidence Interval)
Unit of Measure: Change in mg/kg/min
0.4
(-1.2 to 1.9)
0.7
(-0.6 to 2.1)
6.Secondary Outcome
Title HbA1c
Hide Description Hemoglobin A1c.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for one subject.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 22 20
Mean (95% Confidence Interval)
Unit of Measure: Change in %
0.20
(0.04 to 0.36)
0.02
(-0.07 to 0.1)
7.Secondary Outcome
Title Insulin Like Growth Factor 1 (IGF-I)
Hide Description Insulin Like Growth Factor 1 (IGF-I).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for one subject.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 22 20
Mean (Standard Deviation)
Unit of Measure: Change in ng/mL
79  (92) 7  (62)
8.Secondary Outcome
Title Lipid Panel
Hide Description Fasting lipids. Triglyceride value is given.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for one subject.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 22 20
Median (Inter-Quartile Range)
Unit of Measure: Change in triglyceride, mg/dL
-25
(-68 to 8)
-10
(-33 to 8)
9.Secondary Outcome
Title Carotid Intimal Medial Thickness (cIMT)
Hide Description Carotid Intimal Medial Thickness (cIMT).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 23 20
Mean (95% Confidence Interval)
Unit of Measure: Change in mm
-0.03
(-0.07 to -0.00)
-0.00
(-0.03 to 0.03)
10.Secondary Outcome
Title Glucose Tolerance
Hide Description Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used; data were not available for some subjects.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 22 18
Mean (95% Confidence Interval)
Unit of Measure: Change in 2-hour glucose, mg/dL
-1
(-18 to 15)
-8
(-24 to 8)
11.Secondary Outcome
Title Adiponectin
Hide Description adiponectin.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available data were used. Data were not available for 1 subject.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 22 20
Median (Inter-Quartile Range)
Unit of Measure: Change in ng/mL
0
(-515 to 1159)
0
(-1030 to 515)
12.Secondary Outcome
Title Hemostatic Markers
Hide Description Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Please note that we do not have data for these markers (neither PAI1 or tPA) because we did not have adequate funds to assess these.
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description:
Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 month randomized portion of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tesamorelin Placebo (Inactive Injection)
Hide Arm/Group Description Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
All-Cause Mortality
Tesamorelin Placebo (Inactive Injection)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Tesamorelin Placebo (Inactive Injection)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      3/22 (13.64%)    
Cardiac disorders     
Congestive Heart Failure * 1 [1]  1/28 (3.57%)  1 0/22 (0.00%)  0
Gastrointestinal disorders     
esophageal myotomy * 1 [2]  0/28 (0.00%)  0 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders     
pneumonia * 1 [3]  1/28 (3.57%)  1 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders     
basal cell carcinoma * 1 [4]  1/28 (3.57%)  1 1/22 (4.55%)  1
Vascular disorders     
cerebrovascular accident * 1 [5]  0/28 (0.00%)  0 1/22 (4.55%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
exacerbation of existing congestive heart failure
[2]
Planned Heller myotomy requiring post-procedure hospitalization
[3]
pneumonia requiring hospitalization
[4]
diagnoses of basal cell carcinoma in 2 patients, both of whom had history of basal cell carcinoma in past
[5]
acute cerebrovascular accident
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tesamorelin Placebo (Inactive Injection)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/28 (89.29%)      21/22 (95.45%)    
Blood and lymphatic system disorders     
edema * 1  2/28 (7.14%)  1/22 (4.55%) 
Endocrine disorders     
hyperglycemia * 1  2/28 (7.14%)  2/22 (9.09%) 
Infections and infestations     
sinusitis * 1  2/28 (7.14%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
joint pain * 1 [1]  4/28 (14.29%)  4/22 (18.18%) 
muscle pain * 1 [2]  3/28 (10.71%)  0/22 (0.00%) 
Nervous system disorders     
paresthesia * 1  6/28 (21.43%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders     
injection site bruising * 1  10/28 (35.71%)  11/22 (50.00%) 
erythema at injection site * 1  4/28 (14.29%)  2/22 (9.09%) 
stinging of skin * 1 [3]  3/28 (10.71%)  0/22 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
arthralgia
[2]
myalgia
[3]
stinging at injection site
Please note that we intended to collect and analyze data on PAI1 and tPA but we did not have sufficient funds to do this.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven K. Grinspoon, MD
Organization: Massachusetts General Hospital
Phone: 617-724-9109
EMail: sgrinspoon@partners.org
Publications of Results:
Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA. 2014 Jul 23-30;312(4):380-9. doi: 10.1001/jama.2014.8334.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263717    
Other Study ID Numbers: 2007p-000638
First Submitted: December 16, 2010
First Posted: December 21, 2010
Results First Submitted: September 8, 2014
Results First Posted: October 13, 2014
Last Update Posted: October 30, 2017